Oxytocin adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Oxytocin
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Also reported as: Oxytocin Injection Usp, Oxytocin 10 Units, Oxytocin Injection

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From April 2004 to June 2026, FDA received 1,394 adverse event reports that name Oxytocin. In these reports the drug is a suspect or interacting product.

In the same period, 1,164 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 92 reports in the 12 months to June 2026 and 116 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Oxytocin is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 19 reports that name Oxytocin.
In January to March 2026, FDA received 23.
In April to June 2025, FDA received 29.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 132 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,334 of the 1,394 reports (95.7%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 132 terms.

Reaction terms in the reports that name Oxytocin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,394 reports
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	263	18.9%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	251	18%
Drug ineffectivethe medicine did not work as expected	229	16.4%
Exposure during pregnancythe medicine was taken during pregnancy	156	11.2%
Premature babya baby born early	150	10.8%
Premature delivery	107	7.7%
Off label useused for a purpose or in a way not on the label	87	6.2%
Low birth weight baby	85	6.1%
Maternal exposure during delivery	78	5.6%
Postpartum haemorrhage	64	4.6%
Hypotensionlow blood pressure	50	3.6%
Normal newborn	41	2.9%
Live birth	40	2.9%
Tachycardiafast heart rate	39	2.8%
Drug exposure during pregnancythe medicine was taken during pregnancy	38	2.7%
Haemoglobin decreasedlow haemoglobin	37	2.7%
Anaphylactic reactiona severe, sudden allergic reaction	36	2.6%
Hypertensionhigh blood pressure	36	2.6%
Foetal death	34	2.4%
Hypoxialow oxygen	33	2.4%
Product use in unapproved indicationused for a purpose not on the label	32	2.3%
Pulmonary oedemafluid in the lungs	30	2.2%
White matter lesion	28	2%
Uterine atony	26	1.9%
Foetal exposure during delivery	24	1.7%
Caesarean section	23	1.6%
Condition aggravatedthe condition being treated got worse	23	1.6%
Vomitingbeing sick	23	1.6%
Foetal anaemia	22	1.6%
Pre-eclampsia	22	1.6%
Small for dates baby	22	1.6%
Ventilation perfusion mismatch	22	1.6%
Dyspnoeashortness of breath	19	1.4%
Foetal growth restriction	19	1.4%
Haemorrhagebleeding	18	1.3%
Hyponatraemialow blood sodium	18	1.3%
Metabolic acidosistoo much acid in the body fluids	18	1.3%
Nauseafeeling sick	18	1.3%
Heart rate increaseda fast heart rate reading	17	1.2%
Therapy non-responderthe treatment did not work	17	1.2%
Acute pulmonary oedema	16	1.1%
Overdosea dose above the recommended amount	16	1.1%
Bradycardia foetal	14	1%
Haemodynamic instability	14	1%
Oxygen saturation decreased	14	1%
Pyrexiafever	14	1%
Vaginal haemorrhagevaginal bleeding	14	1%
Cardiac arrestthe heart stopped	13	0.9%
Drug dependencedependence on a medicine	13	0.9%
Medication errora mistake in prescribing, dispensing or taking a medicine	13	0.9%

Download all 132 terms of Oxytocin (CSV)

The counts add to more than 1,394 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Oxytocin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Oxytocin (this page)	Generic name	1,394
Pitocin	Brand name	289

Sum of the separately reported names: 1,683. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Oxytocin, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	22	16	1	3	8	1	0	5	6
2005	9	9	1	0	2	0	0	6	0
2006	26	22	2	4	5	1	0	15	4
2007	19	14	2	4	5	0	0	6	5
2008	28	26	3	2	8	0	0	21	2
2009	19	17	2	1	8	0	0	13	2
2010	24	24	3	11	7	0	0	15	0
2011	22	22	1	2	14	0	2	14	0
2012	13	13	2	1	4	1	0	10	0
2013	30	27	1	1	17	0	0	13	3
2014	58	58	8	3	22	1	4	40	0
2015	39	32	2	3	5	0	0	27	7
2016	38	33	3	2	9	0	0	27	5
2017	59	56	1	17	10	3	1	45	3
2018	68	66	6	6	11	0	2	59	2
2019	85	75	7	8	24	0	2	64	10
2020	98	85	7	15	29	0	2	61	13
2021	114	93	10	10	32	2	1	72	21
2022	135	117	5	22	42	1	2	91	18
2023	184	167	10	10	42	1	5	145	17
2024	130	124	2	8	44	1	1	108	6
2025	124	119	5	12	35	1	1	110	5
2026	50	49	3	9	17	0	0	34	1

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Oxytocin, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Oxytocin, by the year in which FDA received them
Year	Reports
2004	21
2005	10
2006	23
2007	21
2008	29
2009	18
2010	25
2011	22
2012	20
2013	31
2014	56
2015	39
2016	39
2017	66
2018	85
2019	77
2020	100
2021	114
2022	149
2023	186
2024	120
2025	101
2026	42

Reports that name Oxytocin, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Oxytocin
Age	Reports	Share
Under 2	34	2.4%
2 to 11	0	0%
12 to 17	5	0.4%
18 to 44	803	57.6%
45 to 64	18	1.3%
65 to 74	3	0.2%
75 and over	1	0.1%
Age not given	530	38%

Sex of the patient in the reports that name Oxytocin
Sex	Reports	Share
Female	1,036	74.3%
Male	115	8.2%
Unknown or not given	243	17.4%

Type of reporter in the reports that name Oxytocin
Reporter	Reports	Share
Physician	237	17%
Pharmacist	196	14.1%
Other health professional	792	56.8%
Lawyer	1	0.1%
Consumer or non-health professional	116	8.3%
Not given	52	3.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 38.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Oxytocin record
Indication as recorded (MedDRA)	Reports	Share
Labour induction	305	21.9%
Foetal exposure during pregnancy	77	5.5%
Postpartum haemorrhage	52	3.7%
Uterine contractions during pregnancy	39	2.8%
Labour augmentation	33	2.4%
Induced labour	21	1.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,394 reports.

Drugs in the same reports

Other drugs that the reports of Oxytocin name, in any role, in order of name
Drug	Reports that name the two
Betamethasone	120
Bupivacaine	170
Cefuroxime	85
Fentanyl	238
Labetalol	86
Magnesium sulfate	84
Metronidazole	120
Misoprostol	149
Ondansetron	89
Phenylephrine	93

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Pitocin same ingredient
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These links are for navigation. No count selected them.

Official pages

DailyMed labels for OxytocinThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Oxytocin: adverse event reports that FDA received. https://reportedreactions.com/drug/oxytocin/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Oxytocin as a suspect or interacting product. The 1,164 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Oxytocin was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Oxytocin?

No. It is a count of what people reported to FDA: 1,394 reports from April 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (56.8%), physician (17%) and pharmacist (14.1%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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